Smith & Nephew, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1905-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

Product Classification:

Class II

Date Initiated: March 30, 2018

Date Posted: May 30, 2018

Recall Number: Z-1905-2018

Event ID: 79875

Reason for Recall:

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

Status: Terminated

Product Quantity: 72 units

Code Information:

Batch Numbers: 09FM04561; 14AM05774 & 15GM11501

Distribution Pattern:

US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore

Voluntary or Mandated:

Voluntary: Firm initiated